A company owned by the family of shipping magnate Manuel “Matty” Moroun is alleged to have violated state law and federal standards in how its contractors handled asbestos-containing materials during ongoing demolition at the former McLouth Steel site in Trenton, according to the Michigan Department of Environmental Quality.

The DEQ on Tuesday issued a Notice of Violation to Crown Enterprises Inc., a Warren-based development firm run by Matthew Moroun, son of Matty Moroun, and to 21st Century Salvage/Next Generation Environmental Inc., an Ypsilanti-based contractor doing demolition work at the now Crown-owned McLouth Steel site off West Jefferson Avenue.

The long-standing, chronically problematic brownfield site in Trenton is being eyed by the Morouns for a new transportation facility that would fit into the family’s vast shipping and trucking empire. Among the family’s most prominent holdings are the Ambassador Bridge and, until its sale in June 2018 to Ford Motor Co. for a new headquarters, the Michigan Central Station.

The DEQ’s Air Quality Division, in a Jan. 11 inspection, found multiple locations at the demolition site where asbestos-containing products were “friable,” or in a dry, crumbling condition, in violation of both the federal National Emission Standard for Asbestos and the state Natural Resources and Environmental Protection Act, according to the agency’s violation notice.

DEQ Air Quality Division analyst Jeremiah Brown, in the violation notice, notes that when he arrived at the site, he saw contractors removing galvanized metal siding from a mill building on the property, covered in an asbestos product, without wetting the material as required during abatement, causing it to flake and crumble. A dumpster was also full of friable asbestos, he stated.

Similar problems were found at a former maintenance and spare parts warehouse on the property.

A summary of the actions that have been taken and are proposed to correct the violations

The date by which the actions will take place

What steps are being taken to prevent a recurrence

Michael Samhat, president of Crown Enterprises, told the Free Press that it is not doing the work on-site at McLouth itself, but through contractors including 21st Century/Next Generation.

“We’re very confident in the vendors we picked — and that was done with a lot of consultation with the EPA and the DEQ,” he said. “We’ve worked with this company quite a bit. But this is a large, very complicated site, with many different conditions.”

The contractor, working with Crown’s on-site consultants, will craft a response to the DEQ, Samhat said.

“If it’s accurate, it’s going to get resolved,” he said. “If it’s not accurate, we’re going to try to get the differences (between the companies and regulators) resolved.”

A message left with 21st Century/Next Generation’s offices was not returned Thursday.

“Although these reports of increased asbestos levels are deeply disturbing, the system worked — MDEQ was on-site even though the EPA is shut down. As soon as asbestos was found, immediate steps were taken to correct the problem and a violation notice was issued.”

State Rep. Darrin Camilleri, D-Brownstown Township, said a proper cleanup of the McLouth site “is critical to the public health of our community.”

“While it’s deeply frustrating that problems are arising so quickly in this demolition process, I’m glad the MDEQ inspected the site and sounded the alarm,” he said. “I will continue to monitor the situation closely to ensure that these companies are held liable for any damages to our community.”

LIBBY, Mont. — The bleak world of asbestos science is tinged with subtle hues of gray and white, barely perceptible shadows that don’t strike the untrained eye as anything abnormal. But for those whose lives and careers are defined by the hundreds of people sick and dying in this tiny mountain community, the reality of the human tragedy that’s been unfolding here for decades is crystal clear.

Dr. Brad Black runs the nonprofit Center for Asbestos Related Disease, and perhaps more than anyone he sees a clear picture of Libby’s plague — but it’s a picture that muddies the further one strays from the former mining town, and away from its medical professionals who have been charting an alarming rate of asbestos-related lung disease here for nearly two decades.

A doctor in Libby since 1977, Black has been at the front lines of Libby’s asbestos fight, and despite all the fuss that’s been made over Libby in the last 20 years — despite the U.S. Environmental Protection Agency’s 2009 declaration of a public health emergency, the first such designation since the federal Superfund law passed in 1980; despite the more than $575 million spent in cleanup costs; and despite the well-documented asbestos contamination that’s sickened thousands and killed hundreds — Black is still waging an uphill battle.

Still, there’s more to Black’s work than traditional patient care, particularly as he and his colleagues pioneer new and innovative research in an effort to better understand Libby’s rarefied breed of toxic fibers. He and the CARD staff are also striving to educate the broader medical community about how they’re diagnosing asbestos-related health problems, and why they’re interpreting the faint hues of gray and white that appear on thousands of patients’ X-ray and CT images as disease when other pulmonologist colleagues don’t see it.

Lung disease caused from Libby Amphibole asbestos is difficult to detect because it develops subtly and forms a thin layer along the interior chest wall, where it may blend in with shadows, Black said. The scarring of the lungs is progressive in Libby patients exposed to asbestos fibers, so being able to see the scarring and gauge its growth early on through scans is critical for care, he said.

“We’ve tried very hard to get people to see what we’re seeing,” Black said. “Radiology is a gray world. You’re looking at gray shadows and everyone sees it differently. If you don’t know the disease, if you don’t know what you’re looking for, if you haven’t been tracking it here for 18 years, you won’t understand. You’ve got to know what you’re looking for.”

Unfortunately, what Black’s looking for is precisely what he’s finding.

New patients still arrive with metronomic regularity at the CARD clinic, a small medical clinic located off Mineral Avenue. Last year alone, 837 patients were screened and 209 were diagnosed, according to Tracy McNew, CARD’s administrative director.

McNew said that’s a figure that falls right in line with the clinic’s annual diagnostic rate of about 25 percent, which, when taking into account its nearly 20-year existence, portrays a bleak picture.

“Even after all this time, we’re still receiving new patients all the time,” she said.

Two decades ago, the scope of asbestos exposure in Libby came to light when news reports detailed a link between the deadly fibers unearthed at a vermiculite mine operated by W.R. Grace and Co. between 1963 and 1990, and the hundreds of people who were sick and dying because of exposure to asbestos-laden dust.

Two of the diseases most commonly associated with asbestos — asbestosis and mesothelioma — have latency periods of as much as 40 years. That means people who were exposed to the asbestos dust could continue to develop illnesses for generations to come.

“Conservative estimates put us out until 2030, so it won’t go away for a while,” Black said. “Again, those are conservative estimates. It’s really hard to predict how many sick people we’re going to see, but it’s going to be a lot.”

More questions than answers

Still, even as the volume of patients at the CARD clinic continues to swell, there’s a relative dearth of science. That’s because despite the millions spent by the federal government, no real investment has been made in scientific studies that would help answer some basic questions, such as: Does an effective treatment exist? Are there markers, like blood proteins, to help identify asbestos-related disease in patients before the air-constricting symptoms arrive? To what degree do genetics play a role in determining who gets sick? Do autoimmune diseases like rheumatoid arthritis and lupus serve as a precursor to asbestos-related disease and lung cancer? And why does Libby’s particular brand of asbestos, a toxic cocktail of several naturally occurring mineral fibers, cause such devastating disease to people with short-term exposure?

“There’s a real misunderstanding that there has to be a long-term occupational exposure,” Black said. “Even low levels can lead to very serious lung disease. We have people in our population who had very brief exposures and 10 years later they have the disease. The level that it takes to cause significant disease is really hard to believe. But that’s Libby’s pattern.”

Libby’s pattern is unlike that seen in most commercial asbestos, which belongs to a family called chrysotile asbestos, tiny fibers that, when inhaled, spiral into lung tissue like corkscrews. But Libby’s asbestos hails from the amphibole family, dart-shaped fibers that, when inhaled, lodge in the outer lining of the lung, or the pleura, a thin, elastic sac that, when healthy, expands and contracts in time with a person’s breathing.

But when the pleura is riddled with rigid, dart-shaped asbestos fibers, it begins to scar over, rendering the soft, pink tissue that was once thin as plastic wrap into something that’s thick as an orange peel.

Disease that’s the result of Libby’s asbestos can also be tricky to diagnose because it remains latent for years, then progresses at rates that have stunned medical professionals. Black and his colleagues might read abnormalities on a patient’s X-ray or CT images years before the patient ever exhibits symptoms.

Many patients at the CARD clinic request screenings simply because they’ve lived in Libby and may have been inadvertently exposed to the dust.

Because of a provision former U.S. Sen. Max Baucus, D-Mont., inserted into the Obama administration’s health care reform bill, the Affordable Care Act, victims of asbestos-related disease in Libby are eligible for a range of federal health care benefits, including services not normally covered by Medicare. The provision provides funding for screenings, as well as Medicare coverage for all Libby residents with asbestos-related disease.

Under a special Medicare pilot program, the government also pays for services not included under Medicare, such as home care, medical equipment, counseling, help with travel, and medications not covered by Medicare prescription plans.

It’s a boon to current and former Libby residents unsure whether they’ve been exposed.

Asbestos fibers were everywhere

Studies by the EPA explain how the old vermiculite mine on Zonolite Mountain dispersed about 5,000 pounds of amphibole asbestos fibers over Libby every day the mill operated. It was sprinkled on the local ball field, used on the high school track, piled in heaps around the community, trucked away by train, and used as insulation in millions of homes across the country.

“In Libby, there are all kinds of pathways to exposure. It’s not just miners. People played in piles of the stuff when they were kids,” Black said. “A lot of the time we’ll screen hunters who grew up here and suddenly notice they can’t hike uphill any more without stopping every 15 feet to catch their breath.”

The findings in Libby could have larger implications for helping doctors across the country better diagnose people who were exposed to the amphibole fibers and moved away or were exposed to the fibers through one of the many products made with asbestos from the Northwest Montana mine.

Doctors might not recognize the more progressive form of lung disease caused by amphibole fibers, instead believing patients were exposed to chrysotile fibers, which make up 95 percent of asbestos use, Black said.

Still, Black is sympathetic to his colleagues who don’t see what he sees on patients’ scans.

“It’s been a challenge since we started,” he said. “Prior to 2000, we didn’t know anything. It was all a new experience for me because what we were seeing was so different than what we were trained to look for. We didn’t know what we were looking for.”

“This isn’t your grandfather’s asbestos disease,” he added.

In 2017, Black and his colleagues published a groundbreaking study that validated their interpretation of abnormalities they detected in imagery and scans that other radiologists dismissed.

The case involved a 74-year-old former Libby resident who worked as a millwright at the vermiculite mine from 1969 until its closure in 1990. He moved out of the area in 1991, and had no other known exposure to asbestos fibers. In 2011, he developed increasing chest pain, and in 2013 lung cancer screening detected a new, solid nodule that continued to grow on follow-up scans.

When the patient was referred for a lobectomy, a procedure that involves removing a section of the lung, analysis of the tissue revealed physical proof of what Black and his colleagues had detected on the patient’s scans — it was riddled with asbestos fibers, specifically, 5.5 million fibers per gram of wet lung lining.

“Most people would never have interpreted this patient’s scans as positive,” Black said. “And here we had physical proof, not just a radiologist’s interpretation. It was an ideal case because it showed exactly what we have been seeing — a high fiber burden that would not have been recognized as abnormal by most radiologists. Here, we were able to show it and compare it to the finer features of the scan.”

It was the first case in which lung tissue from a Libby miner was evaluated for fiber analysis.

“We know what we’re looking for but to train other people to see it over time is a challenge,” he said.

ANN ARBOR, Mich. — Despite the jackhammer-like rhythm of a mechanical ventilator, Alicia Moreno had dozed off in a chair by her 1-year-old’s hospital bed, when a doctor woke her with some bad news: The common stool softener her son, Anderson, was given months earlier had been contaminated with the bacterium Burkholderia cepacia.

Suddenly, Anderson’s rocky course made medical sense. B. cepacia was the same unusual bacterium mysteriously found in the boy’s respiratory tract, temporarily taking him off the list for a heart transplant. The same bacterium resurfaced after his transplant and combined with a flu-like illness to infect his lungs. He’s been on a ventilator ever since.

The tainted over-the-counter medicine, docusate sodium, routinely prescribed to nearly every hospitalized patient to avert constipation, caused Anderson to suffer “serious and dangerous life-threatening injuries,” a lawsuit filed by his family alleges. The drug was eventually recalled, but only after a Texas hospital staff noticed an uptick in B. cepacia infections, prompting a six-month investigation that led back to the tainted drug and its Florida manufacturing plant.

“Something that was supposed to help him hurt him,” Alicia Moreno said.

Since the start of 2013, pharmaceutical companies based in the U.S. or abroad have recalled about 8,000 medicines, comprising billions of tablets, bottles and vials that have entered the U.S. drug supply and made their way to patients’ medicine cabinets, hospital supply closets and IV drips, a Kaiser Health News investigation shows. The recalls represent a fraction of the medicines shipped each year. But the flawed products contained everything from dangerous bacteria or tiny glass particles to mold — or too much or too little of the drug’s active ingredient.

Over the same period, 65 drug-making facilities recalled nearly 300 products within 12 months of passing a Food and Drug Administration inspection — as was the case with the stool softener, according to a KHN analysis of recall notices and inspection records kept by the FDA.

Those recalls included more than 39,000 bottles of the HIV drug Atripla laced with “red silicone rubber particulates,” nearly 37,000 generic Abilify tablets that were “superpotent,” and nearly 12,000 boxes of generic Aleve (naproxen) that were actually ibuprofen, according to the recall data KHN examined.

The medicine alleged to have sickened Anderson Moreno seriously infected at least 63 other people in 12 states, according to reports by the FDA and Centers for Disease Control and Prevention. The drug was made at a PharmaTech plant in Broward County, Fla. That same plant passed an FDA inspection even while it was making bacteria-laced products, according to a KHN review of the inspection records.

PharmaTech did not respond to KHN’s requests for comment. A lawyer for the drugmaker filed a motion to dismiss the lawsuit in April, but it was not granted. In follow-up court records, PharmaTech has denied claims against it.

Like other FDA commissioners before him, Scott Gottlieb has called his agency’s drug oversight program the “gold standard” for safety and effectiveness.

But veteran industry consultant John Avellanet, who has trained FDA inspectors, questions how effective the FDA’s drug plant inspections actually are. “It’s so easy” for FDA inspectors to miss things because they’re working with confusing regulatory terms and standards that are often decades out of date, Avellanet said.

Just how often people are sickened or die from tainted drugs is next to impossible to determine. No government agency tracks cases unless they’re linked to a major outbreak among hospital patients. And sudden, seemingly random illnesses in disparate places are notoriously hard to link to a tainted drug. That’s in part because drugmakers don’t have to divulge which products are made in which manufacturing plants, since that is regarded as proprietary information.

The result: Even someone who buys drugs for a major hospital can’t track down where a potentially dangerous product came from, said Erin Fox, who purchases medicines for University of Utah Health hospitals.

“Patient safety should come first,” she said, adding that the KHN analysis indicates “our drug quality is probably not what we think it is,” and calling it a “scary” reality. “Something does need to change if this is happening this many times and we’re having patients receiving contaminated products.”

The FDA declined to be interviewed for this story, but responded to written questions.

“While the FDA would prefer that no drug be distributed that later is recalled, we do not think that a recall indicates a failure of FDA inspection and surveillance programs,” FDA spokesman Jeremy Kahn said in an email. He said inspectors “may not uncover all issues or practices that may eventually result in a problem leading to a recall” and that “not all recalls are the result of poor manufacturing practice.”

The PharmaTech Story

“Lucky fin, lucky fin, lucky fin,” Alicia Moreno, 30, cheered as she untangled her now 3-year-old son’s stroke-weakened arm from a sweater and his portable ventilator in the back seat of the car for yet another four-hour drive to see doctors in Ann Arbor, Mich. In the Disney movie “Finding Nemo,” Nemo’s father calls the young fry’s smaller fin his “lucky fin.”

While her husband drives, Alicia pulls out a clear plastic case of syringes and watches the clock on the dashboard. Anderson needs about two dozen different medicines every 24 hours, and Alicia administers them via a port in his belly at designated times.

It wasn’t always like this. Anderson appeared healthy until his 6-month checkup in May 2016, his mother said. Partway through the exam, the Morenos rushed their baby to a nearby hospital and learned he was in heart failure and would need a transplant to survive. That’s where he received the tainted stool softener, his lawyers allege. The hospital where Anderson eventually received his transplant confirmed via email that Anderson tested positive for the same strain of B. cepacia involved in the outbreak traced back to PharmaTech’s contaminated drug.

In July, according to the family, Anderson started to have difficulty breathing and his temperature spiked to 106 degrees, which landed him in the ICU, where doctors and nurses packed him with ice and rushed to find the cause. Their tests turned up positive for B. cepacia, a bacterium found in untreated water that doesn’t typically make healthy people sick. Anderson’s status on the transplant list was put on hold, and his heart condition worsened. He was placed on a machine that transferred blood outside his body, oxygenated it and pumped it back in.

Anderson finally got a heart transplant in November 2016, but four days after doctors closed his chest, his fever was back and his lungs kept getting worse, requiring more complicated machinery. Tests came back positive for a flu-like virus and B. cepacia, according to the hospital.

“Where did he get it?” his parents pleaded. At the time, no one knew.

How Tainted Drugs Slip Through the Cracks

The FDA is supposed to inspect all factories, foreign and domestic, that produce drugs for the U.S. market. But a KHN review of thousands of FDA documents — inspection records, recalls, warning letters and lawsuits — offers insight into the ways poorly manufactured or contaminated drugs reach consumers: Inspectors miss serious hazards. Drugmakers fail to meet standards even after the FDA has taken enforcement action. Hundreds of plants haven’t been inspected for years, if ever.

Last July, for example, the FDA announced the first of many voluntary recalls of the blood pressure medicine valsartan because some tablets contain a cancer-causing impurity called N-nitrosodimethylamine (NDMA). They would later find a similar carcinogen, N-nitrosodiethylamine (NDEA), in valsartan pills. Over the prior two years, investigators had detected worrisome problems in two overseas factories involved in the manufacturing of the drug.

In 2017, FDA investigators found rust, chipping paint and deteriorating equipment at a plant run by Zhejiang Huahai Pharmaceutical Co. in Zhejiang, China. Plant staffers weren’t properly testing and investigating “anomalies” in their drugs, dismissing problematic test results, the FDA said at that time. Inspectors also found “black metallic particles” and other problems in some unidentified drugs.

The FDA inspected the plant in July 2018 after complaints about NDMA from a facility further down the drug supply chain. The FDA put the facility on import alert in late September and issued a warning letter in November detailing deficiencies, including “Failure of your quality unit to ensure that quality-related complaints are investigated and resolved.”

At a facility of Hetero Labs in India, in 2016, FDA inspectors found colored and white residue in components, some of the factory’s tablets were twice as thick as others, and employees were shredding documents in the middle of the night. The FDA issued a warning letter to the company as a result of the inspection.

Plants making drugs for U.S. consumers are supposed to be inspected every few years, according to a risk-based system. However, in the past decade more than 2,500 facilities, both foreign and domestic, have gone more than five years without an FDA drug-quality inspection, a KHN analysis found. The FDA has no drug-quality inspection records over the past decade for more than 1,200 domestic plants and nearly 400 foreign plants, excluding those that make animal drug products, according to the analysis. Gottlieb said in December that he hopes to clear the backlog of uninspected drug facilities by the end of September 2019.

At best, the inspections are a snapshot in time, and involve looking at processes rather than evaluating the drugs themselves, said drug-quality specialist Dinesh Thakur, who has worked for drugmakers. The inspections might take place while the facility is making only one of a dozen or so drugs that it usually manufactures.

“The implicit assumption … is that if the [manufacturing] processes are sound, the product will be of good quality,” said Thakur, who raised the alarm about quality-control problems at generics drugmaker Ranbaxy, resulting in a 2013 guilty plea and a $500 million settlement. “Your data tells us this is not true.”

Many inspections, he said, are “stage-managed,” so that factories pass on the appointed day, but “once the inspectors leave, it’s a completely different story.”

David Gortler, a former FDA medical officer, said most drug plant inspections involve looking over paper records and trusting that they’re real, instead of randomly testing medicines.

“Anybody can write down anything on a piece of paper,” said Gortler, who is now a consultant at FormerFDA.com. He added that FDA inspectors aren’t reprimanded — or even told — if they’ve passed a plant that issued a recall shortly thereafter.

A Lucky Break Solves A Mystery

The contaminated stool softener alleged to have sickened Anderson Moreno was one of many drugs recalled by plants shortly after they passed an FDA inspection. The bacteria was detected only after an outbreak of disease — and after a good deal of medical sleuthing.

More than 1,000 miles away from Anderson’s ICU bed in Michigan, staff at Texas Children’s Hospital’s pediatric ICU in Houston had diagnosed three cases of B. cepacia in one week in February 2016, according to a 2017 medical journal article published in Infection Control and Hospital Epidemiology. It was odd because there had been no cases the previous year.

Hospital staff members embarked on a months-long investigation and by July had identified 24 victims, whose median age was under 2 years old. Patients had the same strain of the bacteria in their blood, their respiratory tracts, their urine or their stool, according to the article.

Samples matched the bacteria found in liquid docusate, the stool softener, the researchers wrote.

The hospital alerted the CDC and other public health officials of its findings. The CDC would eventually identify 63 confirmed and 45 suspected serious B. cepacia infections in 12 states tied to the contaminated drug.

A 36-day FDA inspection of PharmaTech in Davie, Fla., that ended Aug. 9, 2016, revealed that the bacteria was in water used to clean equipment and make liquid products. FDA inspectors concluded that the bacterium made it into the facility’s drugs starting in 2015 and was still present in the water.

Anderson was treated with the stool softener in May 2016. His parents filed suit in September 2017 in PharmaTech’s home of Broward Country, Fla., against the drugmaker and others in the drug supply chain, alleging the drug was contaminated and caused him grievous damage. PharmaTech, which did not return KHN’s requests for comment, unsuccessfully filed a motion to dismiss and has denied all charges in a subsequent filing.

A 9-month-old girl in Pittsburgh who had received the stool softener died on May 4, 2016, according to a lawsuit her family filed in July 2017 in the U.S. District Court for the Western District of Pennsylvania. Her mother learned about the drug recall by chance and asked the hospital whether her deceased daughter received the tainted drug, her lawyer told KHN. The family filed charges against PharmaTech and others in the drug supply chain in a wrongful death lawsuit. The court rejected PharmaTech’s motions to dismiss and strike, and the drugmaker denied liability in a subsequent filing. In November 2017, a lawyer representing PharmaTech in that wrongful death case told the Orlando (Fla.) Sun Sentinel that it will defend itself against the allegations and couldn’t comment further “because of the ongoing nature of litigation.”

According to federal records, FDA inspectors had a chance to catch the contamination during their March 2016 inspection, but the PharmaTech plant passed with no citations. PharmaTech CEO Ray Figueroa saluted the inspection results in a press release, calling it “a testimony to PharmaTech’s commitment to world-class quality.”

How Things Can Go Wrong

The FDA has issued thousands of enforcement actions against drug plants over the years, citing safety violations, issuing warning letters and blocking imports from certain foreign plants. In rare cases, the FDA can also seize drug products and has done so 23 times in the past decade. The last drug seizure was more than two years ago, according to FDA records.

In an emailed statement, FDA chief Gottlieb said the FDA is “taking new steps” to identify problems before they occur and it is “not shy” to use its powers to mitigate risks.

But the system can be stymied or gamed and the FDA’s enforcement abilities are limited. For instance, it doesn’t have the power to issue a mandatory recall, and manufacturing citations don’t come with fines.

Many cases come to light only when a whistleblower sounds an alarm.

Thakur, the Ranbaxy whistleblower, said officials in other countries sometimes tip off plants about “surprise” FDA inspections. And FDA inspectors often have to rely on translators hired by the drug companies, said Avellanet, who has been a drug facility inspection consultant for more than 20 years.

At Nippon Fine Chemical in Japan, employees stood “shoulder-to-shoulder” to keep an FDA official out in December 2015, according to an enforcement letter sent to the plant and published online.

Less than a year later, Vikshara Trading & Investments Ltd. in India allegedly faked a worker strike to block the entrance to the plant, according to an FDA enforcement document that described the manufacturer’s “false statements.” When inspectors were eventually allowed in, the lights were kept off.

“Our investigator had to perform parts of the walkthrough in the dark, using a flashlight,” the FDA warning letter reads, adding that an unidentified powder was “scattered” and “caked on the floor” in production areas and detected on finished drug products.

Two former employees have filed a whistleblower suit against Gilead Sciences, alleging it lied to the FDA about using a drug-manufacturing facility in South Korea, when it was actually using an unregistered facility in China. According to the civil complaint filed in September 2014 in U.S. District Court for the Northern District of California, the ingredient produced at Synthetics China and used in HIV drugs Truvada and Atripla contained “glass-like shards,”

The whistleblowers alleged Gilead’s Alberta, Canada, plant was tasked with sieving contaminants and helping to conceal where the ingredient was made.

They said one batch of the ingredient was contaminated with arsenic, chromium and nickel. Another had a dangerous bacterium called Bacillus cereus, according to the whistleblowers’ suit. Still, Gilead released the product and didn’t initiate a recall, the whistleblowers alleged.

Years after the whistleblowers stopped working for Gilead, the drugmaker issued two voluntary recalls of HIV drugs in 2014, about seven months apart. Both recalls cited contamination with red silicone rubber particulates.

Gilead declined to comment. Gilead has fought the lawsuit, alleging that since the government knew of the allegations and did not penalize it by denying drug approvals or payments, the suit could not move forward. In 2015, a federal judge dismissed the case, but a panel from the 9th District Court of Appeals reversed that decision in 2017. Now the Supreme Court may hear it; in April 2018, it invited the solicitor general to file a brief, “expressing the views of the United States.” The Justice Department filed a brief in November, saying pursuing the lawsuit is “not in the public interest.”

Since the FDA has little power to force a drugmaker to fix problems or issue recalls, FDA inspectors often flag the same violations again and again. A KHN analysis found that over the past decade 70 drug plants — most of them domestic — were penalized for the same violation at least four times. And more than a third of those plants has issued a recall at some point.

Altaire Pharmaceuticals in New York was cited five times by FDA inspectors for inadequate “procedures for sterile drug products.” In 2013, it recalled 363,746 bottles of generic eye drops sold at CVS, Target and Walmart over sterility concerns — namely mold — because the preservative in the product “may not be effective” through the expiration date. Overall, Altaire was told to correct 15 violations at least twice.

KHN attempted to contact Altaire Pharmaceuticals, but the company did not reply.

Kept In The Dark

About a year after the initial PharmaTech recall in 2016, the FDA announced another recall for the same drugs and the same bacterium: B. cepacia. When Erin Fox saw the second recall, she thought it was a mistake. The alert said to avoid drugs made by PharmaTech under several labels “and possibly [products from] other companies.” What other companies? Fox wondered. How could they not know which ones?

Doctors at the hospital asked Fox to remove all PharmaTech-made products from the shelves, but because of lax labeling laws, she said, she couldn’t be sure which those were. Drug labels need to include only the manufacturer, the packer or the distributor — not all three — so the doctors suggested she call PharmaTech and ask what else it manufactures and for whom.

DETROIT (AP) — A deal has been reached between the state and Detroit over the removal of asbestos during the city’s demolition of vacant houses.

The Michigan Department of Environmental Quality announced the consent judgment Friday and says it requires Detroit to operate in compliance with all state and federal asbestos rules.

The agreement also requires the Detroit Building Authority to conduct additional inspections to check for asbestos prior to demolitions. Detroit also must pay a $100,000 settlement, but can submit a proposal for a supplemental environmental project within 12 months which may reduce that amount.

The city has said funding will be withheld from demolition contractors who failed to properly dispose of materials containing asbestos.

Exposure to asbestos fibers in the air can cause cancer and other lung ailments.

Across the country, more than 9,000 lawsuits are pending against Johnson & Johnson that accuse the company of not disclosing that its talcum powder products, such as its famous baby powder, were tainted with cancer-causing asbestos. As juries return million-and billion-dollar verdicts against the company, its representatives are moving to discredit and shift blame onto victims. At one recent trial, they called an expert witness to testify—not only that their product didn’t cause plaintiff Rosalind Henry’s mesothelioma, but that the majority of women’s mesothelioma cases were not attributable to asbestos exposure. I was shocked.

Pushing aside women’s health concerns is nothing new. But this attempt to diminish and dismiss women’s asbestos exposure in a desperate bid to sway a jury is a new low. And it’s a lie.

I thought about what the mesothelioma victims I know, June, Debbie, Janelle, Lou, and Stephanie, would say in response. As friends, we had shared our pain, fears, grief, and anger while they struggled with their disease. But they are gone now, and that’s why I must share their words and speak out for them, and for the other relatives whom they’ve had to leave behind.

“Mesothelioma is a miserable disease.” Debbie (1959-2013)

Here’s the truth: For more than a century, asbestos exposure has been known to cause disease and death. It is a known carcinogen and there is no safe level of exposure or controlled use.

“It was a matter of weeks and I went from being healthy to fighting for my life. I was told I would not survive mesothelioma, that there was no cure.” Janelle (1973-2013)

Unsealed documents suggest Johnson & Johnson feared asbestos, the primary cause of pleural mesothelioma, was in its talc—including its baby powder—as early as the 1970s. According to FairWarning, an investigative news organization that focuses on public health, consumer, and environmental issues, a 1971 Johnson & Johnson memo stated, “It would seem more than appropriate that we upgrade the quality control on our talc and baby powder, particularly as to the potential asbestos content” (emphasis mine). A 1973 internal report acknowledged the presence of this carcinogen at its Windsor Talc Mine in Vermont. What’s worse is that the company appeared to know safe, non-lethal substitutes for talc were available, the same memo stated, “Corn Starch is obviously another answer.”

“I’m 58 and I have been murdered in slow motion. There is no safe form of asbestos and no safe level of exposure.” June (1950-2009)

Women get sick and die every year because of asbestos exposure. In fact, it was a woman, Nellie Kershaw,whose case was first documented in medical literature and whose death led to publication of the first Asbestos Industry Regulations in 1931.

From 1999 to 2016, nearly 50,000 Americans died from mesothelioma, 20 percent of them women —the vast majority due to some type of asbestos exposure. It’s true: More men were, and are, exposed to asbestos through their work. However, women still suffer. Some are exposed at on the job, others in their homes. In some instances, their husbands or fathers may have carried asbestos home from work and into the house. In 1987, the International Agency for Research on Cancer reported “a third of the mesotheliomas occurring in the USA may be due to nonoccupational exposure.” Even more heartbreaking are cases that stem from a child who hugged a parent who wore asbestos-contaminated clothing.

“My father worked in the building trade in the 1970s and died a terrible. painful death of pleural mesothelioma in 1985 after only six months …. Being diagnosed with this cancer through no fault of mine has cut my life short!” Lou (1954–2017)

Mesothelioma is just one of many asbestos-caused diseases. Asbestos also causes lung, ovarian, laryngeal cancers, and respiratory diseases such as asbestosis. Women die from this toxic substance. They get cancer because of this toxic substance. No expert, no testimony, can erase that fact.

Companies like Johnson & Johnson sold products contaminated with asbestos after studies showed the link between powders containing talc and incidences of disease. In court today, Johnson & Johnson is still trying to shirk its responsibility—to ignore the evidence that these chemicals have had a unique and terrible impact on women’s health.

Enough is enough. Most countries around the world have banned asbestos, yet women and families in America are still exposed to this carcinogen far too often. Johnson & Johnson isn’t alone. In 2015, Colgate-Palmolive faced multimillion-dollar lawsuits for cancers caused by its asbestos-contaminated talc products. These are products that have been specifically targeted toward women, including young women. Without a ban, we also import millions of dollars worth of asbestos-contaminated consumer goods every year. Independent testing found asbestos in children’s toys, crayons, and cosmetics as recently as 2018.

Asbestos also infects our schools. In 1990, EPA reported to Congress that one in four schoolchildren and their teachers are at risk of being exposed in the classroom. Then in September, the EPA Office of the Inspector General noted the situation has worsened, as schools have failed to make and follow plans to keep students safe from asbestos. The full extent of the remaining hazard is currently unknown. We have to take action.

“My physical life is a shadow of what it used to be.” Stephanie (1977-2015)

History is a great teacher to those who listen. June, Debbie, Janelle, Lou, and Stephanie, paid the ultimate price for corporate greed. While there is no rewind button for them, nor their families, there is a way forward: Congress and the EPA can embrace legislation to end the asbestos man-made disaster and spare more families their grief.

The town of Libby is a striking and tragic example of corporate irresponsibility, weak regulation and the deadly effects of asbestos exposure. And it’s not just Libby. Nationally, the epidemic of deaths from asbestos exposure shows no sign of slowing down — it’s estimated that nearly 40,000 people die from asbestos exposure each year in the USA alone.

Asbestos is a known human carcinogen and experts agree that no amount of use of the toxin is safe. The European Union already prohibits its use, and despite this ominous classification, the United States is woefully lagging behind in the banning of asbestos.

Asbestos-related deaths in the United States demonstrate how our regulatory system for managing chemicals in the U.S. — known as the Toxic Substances Control Act (TSCA) — has failed to protect the public. For example, the U.S. Environmental Protection Agency tried to ban asbestos in 1980s, but despite the overwhelming evidence of its deadliness, a court ruled in 1991 that the EPA failed to clear all the hurdles under this law.

When Congress passed bipartisan legislation in 2016 strengthening TSCA, many thought it would pave the way to banning asbestos use in the U.S. In fact, that was the intention under the newly strengthened TSCA and the accompanying regulations written by the Obama administration.

Under the Trump administration, the EPA issued a significant new use rule (SNUR) which opens the door to allowing old uses of asbestos to return to commerce. Given the scientific community’s consensus that no amount of use of asbestos is safe, allowing these old deadly uses to resume will surely mean more lives lost. And the sad reality is that if imports of the toxin are not banned, manufacturers will continue to use it.

What’s even more frightening is that we don’t have a clear picture of how much asbestos is entering the United States because manufacturers are not required to report this information to the EPA. In an effort to change this, a petition was recently submitted to the agency by the Asbestos Disease Awareness Organization and co-signed by Montana-based Women’s Voices for the Earth.

The petition asks the EPA to use their new authority under TSCA to require importers of asbestos-containing materials to report the quantity of the toxin and the types of products it’s found in. Without this information, we have no idea who is importing the chemical or where it’s being used, making it very difficult to limit exposure or even assess the risk posed to workers, who are often disproportionately impacted, and the public. Of course, the end goal isn’t just to secure our right to know where it’s being used — it is to ban asbestos.

The Alan Reinstein Ban Asbestos Now Act of 2017 (SB 2072) has been introduced in Congress that would give the EPA the authority to ban asbestos. U.S. Sen. Jon Tester is an original co-sponsor of the bill. U.S. Sen. Steve Daines has not signed on as a co-sponsor.

The people of Libby are living out a horrible tragedy, and they deserve for it to mean something more. They deserve for it to result in a change that will protect others from enduring the same illness and loss. We cannot simply let the town be a cautionary tale of what happens when regulations don’t go far enough to protect public health, even when there is clear evidence of danger. We need to act. We need our leaders to act and finally ban the import and use of this insidious toxin.

]]>http://serlinglawpc.com/2018/11/14/allowing-asbestos-to-continue-to-kill/feed/0IPS Steel working to get rid of asbestos at former Hennepin millhttp://serlinglawpc.com/2018/10/18/ips-steel-working-to-get-rid-of-asbestos-at-former-hennepin-mill/
http://serlinglawpc.com/2018/10/18/ips-steel-working-to-get-rid-of-asbestos-at-former-hennepin-mill/#respondThu, 18 Oct 2018 19:49:15 +0000http://serlinglawpc.com/?p=1997

HENNEPIN — Demolition has begun at the former Hennepin steel mill, an attorney confirmed this week.

IPS Steel of Michigan, former owner of the mill, has the goal of demolishing and salvaging the entirety of the property as quickly as possible to ensure it’sfree of asbestos, said IPS Steel attorney Andrew Bossory.

On Sept. 27, a judge granted a motion allowing IPS Steel of Michigan to enter into a demolition contract with Alessio and Sons Co. of Illinois, according to online court records.

IPS Steel is the mortgagee in possession of the mill, but Hennepin Industrial Development is still the owner.

The explosion on Friday, August 10, put 15 contract workers in local hospitals. Three were still receiving additional treatment as of Saturday night, according to a statement released to WDIV-TV (Channel 4) by U.S. Steel. The statement also indicated that all those injured were employed by Songer Steel Services.

The Occupational Safety and Health Administration, which governs workplace safety, has cited the U.S. Steel facility for numerous safety violations in the past and charged Songer with more than $30,000 in penalties for violations at the plant, according to state records.

In the past five years, three people have been killed at the Great Lakes Works plant. In December 2013, a U.S. Steel employee was killed when molten metal lit the shanty he was in on fire. In April 2014, a contracted crane operator was killed when the crane he was in tipped over. In April 2015, a U.S. Steel employee was run over by a truck and killed at the plant.

The Great Lakes Works plant has been cited with 20 “serious” safety violations in the past five years and instructed to pay more than $33,000 in penalties. Some of these cases are pending.

For its part, Songer Steel has faced eight “serious” violations and paid $32,500 between two closed cases.

(CNN)The US Food and Drug Administration said it found an additional “unexpected impurity” in three lots of Torrent Pharmaceuticals’ recalled valsartan drug.

Several pills that contain valsartan, a generic ingredient that helps people with high blood pressure and heart failure, have been under a voluntary recall since July. The drugs were tainted with N-nitrosodimethylamine, or NDMA, an impurity that is considered a possible carcinogen by the US Environmental Protection Agency. It’s an organic chemical used to make liquid rocket fuel and a byproduct from manufacturing some pesticides and processing fish. NDMA can be unintentionally introduced into manufacturing through certain chemical reactions.

Not all versions of the drugs have been recalled, but the FDA keeps a regularly updated list of the drugs that have been impacted.

On Thursday, the FDA said that three lots of the drugs made by Torrent Pharmaceuticals were contaminated with a second impurity, N-Nitrosodiethylamine, or NDEA, which is also a suspected human carcinogen. The agency began testing the recalled products and the pills that have not been recalled for the substance after it learned that Zhejiang Huahai Pharmaceuticals found NDEA in several batches of its valsartan active ingredient. Not all batches have been found to be contaminated.

What to do if you take valsartan

If you are worried your drug could be on the recall list, talk with your doctor or pharmacist before changing any routine with your medicine. Because not all valsartan drugs are involved in the recall, they might be able to switch you to a version of the drug made by another company.

If you know your drug is on the recall list, the FDA suggests you continue taking it until your doctor or pharmacist provides a replacement.

The FDA said it will continue to test all products containing valsartan for NDEA impurities as well as the NDMA. Testing should wrap up in the next few days.

“As we continue to investigate the root cause of the impurities found in products that contain valsartan, our scientists are testing these products to better understand these impurities and to ensure they’re not present in other products. We’re also taking steps to make sure we’re providing stringent oversight of manufacturing processes to reduce the likelihood that impurities could be introduced into other products,” said FDA Commissioner Dr. Scott Gottlieb. “As we expand our investigational efforts, we’ll continue to make sure the public has the most up-to-date information. We’ll also continue to work with global regulatory agencies to learn as much as we can about how these impurities came about and how they may affect patients’ health around the globe.”

If you or a loved one have taken the High Blood Pressure Drug Valsartan and have been diagnosed with any of the cancers listed above, please call the Law Firm of Michael B. Serling at (248) 647-6966 or toll free at (800) 995-6991. or Click on the: Free Evaluation